Sedation and Pain (The Effect of IV Sedation on Pain Perception)

This study has been completed.
Sponsor:
Collaborator:
American Society of Regional Anesthesia
Information provided by (Responsible Party):
Michael Froelich, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00853333
First received: February 26, 2009
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

The investigators propose to evaluate the potential effect of sedation on pain perception in two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's brain activation using fMRI(objective).


Condition Intervention
Pain
Drug: dexmedetomidine
Drug: midazolam
Drug: propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Sedation and Pain (The Effect of IV Sedation on Pain Perception)

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Pain Rating Change [ Time Frame: Sedation ] [ Designated as safety issue: No ]

    Mechanical Slide Algometer (www.decisionaidsonline.com), Range: "No Pain Sensation" (1) to " Most Intense Sensation Imaginable" (10) 10 point scale.

    Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention.



Enrollment: 86
Study Start Date: November 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol
Administration via an IV
Drug: propofol
Active Comparator: Midazolam
Administration via an IV
Drug: midazolam
Active Comparator: Dexmedetomidine
Administration via an IV
Drug: dexmedetomidine

Detailed Description:

We propose to contrast and compare the effect of propofol and midazolam, two GABA-related sedative drugs, and dexmedetomidine, an alpha-2 adrenergic agonist, on pain perception in human volunteers by asking a participant to rate their pain and by evaluating a subject's brain activation using fMRI.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy subjects

  • 19 years or older able to follow study instructions

Exclusion Criteria:

  • Age less than 19 or greater than 40
  • Pregnant female
  • Obesity (BMI > or =35)
  • Non-English speaking/reading participants
  • Sleep apnea
  • Pulmonary problems such as moderate or severe bronchial asthma
  • Cardiovascular problems such as hypertension
  • History of claustrophobia
  • Presence of a pacemaker, defibrillator, surgically placed metallic object (e.g., hip replacement)or other implanted device
  • Presence of an unremoved bullet or shrapnel in the body
  • Presence of a prosthetic that is not removable
  • Presence of a hearing aid needed for hearing
  • Head girth exceeding that of the head coil used in the magnet
  • Extensive metalwork on or in teeth, or irremovable false teeth or bridgework
  • Epilepsy
  • Chronic analgesic medication
  • Excessive tattoos (due to local skin heating with tattoos containing ferromagnetic particles)
  • History of surgery for which details are unavailable
  • Allery due to study drugs
  • History of drug abuse
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00853333

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
American Society of Regional Anesthesia
Investigators
Principal Investigator: Michael A Froelich, M.D. University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Michael Froelich, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00853333     History of Changes
Other Study ID Numbers: F081016014
Study First Received: February 26, 2009
Results First Received: August 23, 2013
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
Pain
Propofol
Dexmedetomidine
Midazolam
Effects of sedation on pain perception.

Additional relevant MeSH terms:
Propofol
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on September 18, 2014